Designing for the Medical Device Industry: Holistic Solutions

By Helene

This post originally appeared at Core77.

A Multi-Faceted Approach

Bringing a consumer product to market is a challenge in and of itself—taking an idea through concept development, business analysis, beta testing, product launch, and beyond. Add the FDA (Food & Drug Administration) to the mix, and it’s a whole ‘nother story. This is the challenge faced by medical device and product firms, which not only have to make a fully functioning, well-designed product but also have to put it through several rounds of rigorous testing by the FDA and other regulatory bodies.

The AliveCor heart monitor, designed by Karten Design.

“They’re parameters. They don’t stop you from doing anything, but they do make you do it in a way that you, as a user, would probably think is a good thing,” says Aidan Petrie, Co-Founder and Chief Innovation Officer of Ximedica,

an FDA-registered product development firm with an exclusive focus on medical products. On any given day, Ximedica is running 40 individual programs, overseeing the steps required to bring these products to market. “We don’t do anything that isn’t a FDA-regulated product,” says Petrie.

The timelines for these projects can run anywhere between two to six years. While time-to-market is not the primary driver, finding ways to close that gap can make a big difference in profitability. For companies like Ximedica and HS Design, closing that gap meant becoming International Organization for Standardization (ISO) 13485 certified. “There are so many regulatory and quality metrics that had to be put in place to satisfy those requirements that it made us a better and stronger company,” explains Tor Alden, Principal and CEO at HS Design (HSD). “It also put us to a level where we couldn’t just accept any client. We had to become more sophisticated as far as who our clients were and how we could say no or reach a point of compliancy.” By building those regulations into the design process, these companies are able to anticipate and plan for any potential timely obstacles from the get-go.

As the products become increasingly complex, so do the regulations around how they’re developed. Traceability of every decision is required for ISO and FDA compliance, ensuring that medical device firms have a standardized quality management process that they follow and document every step of the product’s development. Depending on the type of product, specialists are often brought in to advise different aspects of that process. “There are so many parts to the puzzle,” says Petrie. “We have a hundred and forty people, but we still need specialists all over the place. We have regulatory people on staff, but we also bring in other pieces that we need. While all the people we have in the building are experts in medical device development, when we need someone to develop some optics, we go outside for that. It’s very collaborative because nobody can do it all by themselves.”

As an FDA-registered developer and contract manufacturer, Ximedica takes products all the way through to clinical trials—a part of the process that comes with its own set of requirements all its own. Even a product as benign as a toothbrush, for example, calls for regulations under HIPPA (Health Insurance Privacy and Accountability Act) if it is being tested by people over the age of 65, under 18, or those living with certain medical conditions. Being able to connect these requisitions to product features in the beginning would allow a project manager to track deliverables and foresee any hurdles before the final design goes to Verification and Validation.

Concept design of a smartwatch

Companies like Dassault Systèmes hope to offer a holistic approach to these problems. Similar to how Ximedica has positioned themselves as the one-stop-shop for all of the components needed to bring a medical product to market, Dassault Systèmes’ Ideation & Concept Design for Medical Device creates a space for designers, marketers, specialists, and collaborators to bring an idea through all the phases of the design process. Powered by their 3DEXPERIENCE® platform, Ideation & Concept Design for Medical Device brings together automated market listening, 3D-drawing to 3D-design integration, traceability, and project management together in one program—in the cloud.

“It’s very challenging to get a medical product to market in less than two years,” explains Alden. “A lot of it has to do with how challenging it is from the FDA standpoint and getting it through the regulatory bodies, but a lot of it is making sure that everybody is working with the same sheet music. Most important is to capture the user needs upfront and translate them into quantifiable attributes.  Additionally we need to combine these user needs with the technical issues into a product requirement specification.  Managing all these aspects of a project, understanding all the players, and the regulatory milestones is vital to shortening the time to market.”

Check out Beyond the design of the Medical Device to dig deeper into this topic and access the “Ideation & Concept Design for Medical Device” information kit here, over on Dassault Systèmes’ site: Ideation & concept design for medical device.

Foamy Headphones and Smelly Clothes: Designing for the Second Moment of Truth

By Estelle

This post originally appeared at Core 77

High tech products

News about a bad product experience travels quickly. Maybe it’s because of the fact, according to a white paper “Designing for the User Experience,” that five times as many people will tell a friend about a bad experience than a good one, or that social media makes it easier than ever to share that negative message, but news of design shortcomings and failures spread fast.

If I’m buying a pair of headphones and the sound is good, but they’re not comfortable, they’re too small for my head, they are too foamy… I’m not going to have a good Second Moment of Truth with that,” explains Stuart Karten, Principal and Founder of Karten Design.

The same goes for a bottle of laundry detergent you may have purchased for its swanky packaging: if your clothes don’t come out smelling clean, you probably won’t buy it again. That Second Moment of Truth (SMOT) often relies on the user experience, what happens when a consumer actually uses the product. As more and more of those products move towards the digital space, that experience comes down to a digital interface, the intuitiveness of those interactions and ease of use. Karten elaborates:

In general, there are multiple trends that are happening in the consumer electronics arena. One is that things are becoming rectangular boxes with user interfaces. The “stickiness” and the appeal and the connection are moving into the digital space. That puts a lot of challenge on—not only the overall form factor of the product on that first level—but the second level of that digital engagement”.

There are other challenges as well when it comes to designing high-tech consumer electronics. “With High-Tech, the technology is usually brand new, so this thing that you are designing is actually morphing as you move down the development cycle because, as time is changing, the technology is advancing,” explains Rob Brady, CEO and Design Director at ROBRADY, which focuses on consumer, industrial, marine and medical products.

Both Karten and Brady agree that designing for that second level requires a user-centric approach, spending time with the target audience to anticipate and better meet their needs. For electronics and other high-tech goods, that means understanding the incentives behind why a consumer would want this product and the motivation behind their purchases. “People make a conscious decision that they want a new pair of headphones, a new laptop,” says Karten. “They want it to define who they are and the person they want to be.”

Watches rendering

Designing with a broadly aspirational approach often means putting a series of virtual prototypes in front of focus groups, simulating interaction and providing a realistic rendering that can then be iterated upon before even printing out a physical prototype. Once the limits of virtual prototyping have been reached, focus groups can be brought in and products are placed in their hands. As these products move into the digital space, however, so do those focus groups and companies like Dassault Systèmes are creating solutions that virtually emulate the product development process from coming up with a concept to testing it in a online retail or working setting.

Ideation & Concept Design

You build a model and you test it. You do an alpha and you test it. You do a beta and you test it. You prototype early and often,” says Brady. “At the end of the day, it’s all about humans interacting with products and designers making these different products approachable and accessible.”

Do not miss the new edition of MADEin3D contest “Cup of IoT”, featuring the theme of Internet of Things! Register to the MadeIn3D community to enter the contest now! Also, you will want to check out our white paper titled “Designing the User Experience”.

Enter the Cup of IoT contest!

Spotlight on Becher Neme: BIM Expert Pushes a Zero-Change-Order Approach

By Akio

The team that makes up Neme Design Solutions, a Long Beach, California-based BIM consultancy, specializes in simplifying highly complex projects to enable fabrication.

Led by founder Becher Neme, the firm includes a small team of architects and engineers with more than a decade of experience working onsite with general contractors, and with particular expertise in the CATIA solution.

This combination of field experience and software knowledge has helped the firm carve out a unique niche in model clash detection and resolving interface challenges.

Yesterday’s Improvements Are Today’s Inefficiencies

While Neme notes that the AEC industry has flocked to BIM as a means for improving construction efficiency, the tools commonly used require certain sacrifices.

Case in point, one of the firm’s primary services is coordinating clash detection among BIM models. Today, most general contractors launch a project by meeting with all of the trade contractors.

Dozens of people bring their 3D models and, through a seemingly endless series of meetings, they run clash detection to find potential conflicts among systems. When conflicts are found, each model is updated with the solution.

Neme left these meetings wondering: how much time is invested in preparing for these meetings? How much money is spent on getting all parties involved on the same page? If BIM is about providing project efficiency, how can this process be made more efficient?

A Single-Source Solution

While clash detection can be easy, there’s value to be gained in resolving these conflicts more efficiently. To do so, Neme Design Solutions has explored the single-source model concept.

The idea is that Neme Design Solutions works with the general contractor to create an accurate BIM model before subs are brought on board. A small, highly skilled team creates a highly accurate model. As much as 90 percent of the conflicts can be resolved at this stage.

Tweet: An accurate #BIM model can resolve 90% of #AEC conflicts before subs are brought in @Dassault3DS @becherneme http://ctt.ec/Uyh5a+

Click to tweet: An accurate #BIM model can resolve
90% of #AEC conflicts before subs are brought in

Next, the trade contractors are brought in. Rather than resolving hundreds of modeling conflicts, this wider group fine-tunes the existing model before moving directly to fabrication and installation.

The Peak of Precision

This single-source solution is already in action on several of Neme’s projects.

Among them, the Anaheim Regional Transportation Intermodal Center required the high-precision work for which the CATIA software solution is best known. The project features a highly complex ETFE roof with more than 3,000 connection components.

Anaheim Regional Transportation Intermodal Center

(images courtesy of Neme DS)

The roofing contractor brought Neme Design Solutions onboard when the sub determined its software could not handle the roof’s intricate geometry.

By developing a comprehensive, single-source 3D model, the roofing team was able to extract fabrication drawings so accurate that only four of the 3,000 components ultimately needed changes.

Anaheim Regional Transportation Intermodal Center nodes

Anaheim Regional Transportation Intermodal Center nodes

Anaheim Regional Transportation Intermodal Center nodes

But it is Tivoli Village—a mixed-use development in Las Vegas—that perhaps best demonstrates the unique benefits possible from single-source models.

General contractor Hardstone Construction took complete charge of this 2 million square foot project. As part of a small team of CATIA experts, Neme was deeply involved in developing a single-source model for the project. He rendered the MEP part of that model to be conflict-free and ready for installation.

Tivoli model

With the help of this process, the $350 million first phase of the Tivoli Village was so efficient that it had virtually no change orders. The general contractor was able to beat the budget in several areas.

Tivoli village

(images courtesy of Neme DS)

Tweet: Single-source #BIM models allowed a $350M proj to yield virtually no change orders #AEC @Dassault3DS @becherneme http://ctt.ec/b6b3_+

Click to tweet: Single-source #BIM models allowed
a $350M proj to yield virtually no change orders

Next Generation Possibilities

Given the promise of single-source models, Neme is looking to what might soon be possible.

The next generation, he suggests, must move 3D models beyond visual representation and conflict resolution tools. Future models should improve installation workflow onsite, further optimize prefabrication, reduce material waste and raise onsite safety standards.

For Neme, CATIA is far and away the preferred platform for creating complex, yet flexible, models. However, he notes that given Dassault’s game-changing results in the aerospace industry, expectations are high from construction players on what the software company can do to transform their standard processes.

Neme notes that the latest update to Dassault’s platform boosts the software to a truly collaborative tool. The cloud-based platform allows project teams to work live in a model from anywhere around the globe. Updates are instantly visible to the entire team.

This capability allows the specific skill set offered by Neme Design Solutions to be available as-needed worldwide, and allows Neme and his team to work on multiple projects across the world at once.

Where to Learn More

Looking to learn more about single-source models? Consider attending this year’s 3DEXPERIENCE Forum in Las Vegas, November 11-12, where Neme is a returning speaker.

For Neme, the event is a must-attend for anyone interested in innovative solutions, as it exposes attendees to how the technology currently being explored in construction is being used in aerospace, industrial design, medical and other highly successful industries—suggesting new possibilities for how construction can move forward.

For more on the 2014 3DEXPERIENCE FORUM, visit: www.3ds.com/3ds-events/3dexperience-forum-nam

Tweet: A Zero-Change-Order Approach for #AEC from #BIM Expert and #3DXforum Speaker @becherneme | @Dassault3DS http://ctt.ec/55958+

Click to tweet this article


Related Resources

Visit Neme Design Solutions

Connect with Becher Neme on LinkedIn

Learn more about AEC solutions from Dassault Systèmes

Attend the 3DEXPERIENCE Forum, Las Vegas, November 11-12:

3DEXPERIENCE Customer Forum 2014

 




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